A Randomized Comparison Study of Aquacel Ag and Glucan II... | NCT00581217

Studies
A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings

NCT00581217

Sponsor

University of California, Irvine

Status

Terminated

Last Update Posted

Jul 23, 2018Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Burns

Interventions

Aquacel Ag
Glucan II

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study Investigator has suddenly died, study has no results.

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Mar 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 26, 2007

First Posted Date

Dec 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2018

Last Update Posted Date

Jul 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The research will be looking at patient outcomes for healing of donor sites after a split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time, infection rate, cosmetic outcome, and patient's rating of pain will be compared between two donor site dressings, Glucan II and Aquacel Ag.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm study		Burn patients or patients with skin loss requiring split-thickness skin graft	Other: Aquacel Ag Other: Glucan II

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aquacel Ag	Other	Aquacel Ag will be applied to one donor site.	Single arm study

Measure	Description	Time Frame
Healing time		7 - 14 days

Measure	Description	Time Frame
Infection rate		1-21 days
Cosmetic outcome		6 months
Pain rating

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults over age 18 who have sustained a 1 - 30% total body surface area burn or skin tissue loss and require skin grafting

Exclusion Criteria:

Individuals under the age of 18.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Burn injured patients or patients who have had full thickness skin loss requiring skin grafting and donor site dressings

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marianne E Cinat, MD	University of California, Irvine	Principal Investigator
Suzanne Bailey, PT	University of California, Irvine	Principal Investigator
Melissa Carmean, PT, CWS, BS	University of California, Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California Irvine Medical Center		Orange	California	92868	United States

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D010146	Pain

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided